Pathophysiology of Central Apnoeas in Stroke Patients

November 5, 2012 updated by: MPons

Central Apnoeas in the Course of Transient Ischemic Attack/Ischemic Stroke: Clinical, Prognostic, Pathophysiological Elements.

40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of stroke show a respiratory pattern characterized by central apnoeas and/or periodic breathing.

Clinical studies conducted in patients with hearth failure and central apnoeas have demonstrated the pathogenetic central role of hypersensitivity of central and peripheral chemoreceptors in association with baroreflex hypersensitivity, expression of hyperactivity of sympathetic nervous system.

The joint study of chemoreflexes and baroreflexes in patients with central apneas during the acute and subacute phase of ischemic stroke represents, to our knowledge, a novelty in literature, that should supply useful elements to clarify the pathogenesis and the clinical and prognostic significance of these disorders.

Investigators expect a difference in the analysis of the baroreflexes and chemoreflexes in patients with ischemic stroke/transient ischemic attack (TIA) and central apnoeas than patients with ischemic stroke not accompanied by respiratory problems and compared with healthy controls.

Study Overview

Status

Unknown

Conditions

Detailed Description

Investigators expected to include in the study of 120 patients, aged between 35 and 75 years, belonging to the following diagnostic categories:

  • 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas)
  • 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h)
  • 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography
  • 30 healthy controls matched for age, sex, race and BMI.

For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the cardiac rate (RR interval) and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.

For the study of central chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of Oxygen partial pressure (PaO2). The ventilatory response to hypercapnia is calculated by the method of linear regression and is represented by the angular coefficient of the straight line that describes the variation of ventilation for each variation of alveolar carbon dioxide partial pressure (PCO2).

For the study of peripheral chemoreceptors will be used the single-breath or transient hypercapnia test. The patient makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. It is expected, therefore, a period of 3 seconds, required because the gases contained in the mixture may come from the pulmonary circulation to the peripheral circulation, at the level of peripheral chemoreceptors. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Ticino
      • Lugano, Ticino, Switzerland, 6903
        • Recruiting
        • Ospedale Civico
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Pons, MD
        • Sub-Investigator:
          • Alessia Riglietti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Patients

    • ≥35 years old and < 75 years old
    • with clinical diagnosis of TIA or ischemic stroke
    • admitted in a Stroke Unit within 2 days from onset of symptoms
    • signed Informed Consent

Exclusion Criteria:

  • Patients

    • with unstable clinical situation (cardio-respiratory or life-threatening medical conditions)
    • currently on continuous positive airway pressure (CPAP) or on CPAP during the last 3 months before stroke
    • with non-ischemic events (intracerebral/subarachnoid haemorrhage)
    • Patients with coma/stupor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Central Apnoeas Patients
• 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas)
Obstructive apnoea patients
• 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h)
No SDB patients
  • • 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography
Healthy controls
• 30 healthy controls matched for age, sex, race and BMI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baroreflexes
Time Frame: 3 months
For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the RR interval and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.
3 months
Chemoreflexes
Time Frame: 3 months
For the study of central and peripheral chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of PaO2, and the single-breath test in wich the subject makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnoea-hypopnoea index (AHI)
Time Frame: 3 months
Assessing prognosis and spontaneous temporal evolution of central apnoeas in patients with cerebral ischemic events.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MPons

Collaborators

University of Milan
University of Geneva, Switzerland
Advisory Board of scientific Reserch Ente Ospedaliero Cantonale, ABREOC

Investigators

  • Principal Investigator: Marco Pons, MD, Ospedale Regionale di Lugano - Civico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC.NSI.12.04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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